Diana Ryder Kaminsky, MBA, CAE Vice President

Strategy and Market Development 17 November 2016

RAPS Regulatory Competency

Framework

RAPS Overview

• Established in 1976

• Non-political, independently funded, not-for-profit

• Headquartered in metro Washington, DC

• Chapters and affiliates throughout North America, Asia, Europe and Latin America

RAPS Members

• 15,000 individual members in 80 countries

• Members from industry, government, research, academic and clinical organizations

• Studies the changing role of the regulatory profession

• Facilitates careful study and balanced discussion of changes shaping the regulation of healthcare products worldwide

• Develops standards for knowledge, competency, ethics

RAPS Initiatives

RAPS Mission

• Develop and sustain a competent global regulatory workforce that drives good regulatory practice and policy to advance public health.

Registration

R&D

Preclinical

Clinical

Compliance

Manufacturing

REGULATORY

Postmarket Surveillance

Healthcare Product Lifecycle

RAPS Regulatory Competency Framework

LEVEL 4

LEVEL 3

LEVEL 2

LEVEL 1

Executive regulatory leader and strategist Typical job titles (industry): VP, executive director, CEO; (regulators): division director, agency director

Translate regulatory, scientific, operational and business knowledge into strategy Typical job titles (industry): director; (regulators): senior reviewer, section manager

Regulatory technical expertise; managing regulatory functions Typical job titles (industry): manager, senior manager; (regulators): reviewer

Support work of regulatory team; building regulatory knowledge base Typical job titles (industry): coordinator, specialist

Professional Levels

Scientific & Health

Concepts Ethics

Business Acumen

Communication

Leadership Regulatory

Frameworks & Strategy

Product Development

& Registration

Postapproval/Postmarket

Professional Competency Domains

Competencies for Each Career Level

Sample Domain: Postapproval/Postmarket

Knowledge of requirements and processes to maintain a product on the market; reporting and surveillance.

Level 1

Level 2

Level 3

Level 4

Maintains, assists, tracks…

Reviews, assures, submits, participates

Develops, reviews, approves, adapts, understands

Approves, integrates, leads, represents

Progression of Competencies

Level 1

Level 2

Level 3

Level 4

Strategic

Operational

Tactical

Career Development Planning Process

Self Assess Strengths and Weaknesses

Determine Your Regulatory

Professional Level

Discuss the Results

Skill, Knowledge,

or Ability

Individual Learning

Style

Amount of Available

Time

Write SMART Development

Objectives

Structure Environment to Support Learning Transfer

Stay Engaged Identify

Potential Resources

Applying Framework to Career Development Planning for Organizations

Applying Framework to Career Development Planning for Individuals

Career Development Points To Consider

• Multiple paths into the profession

• Company size/structure impact roles

• Individuals and organizations need a destination and a plan

• Career/professional development are investments for the future

• Regulatory knowledge and business-communication skills are critical

RAC is the only accredited post-academic credential for

regulatory professionals

Regulatory Affairs Certification (RAC)

• Exam-based; developed from extensive job analysis studies

• 7,000 professionals have earned the RAC credential

• RAC program is guided by RAC Board and exam committees

• Spring/autumn testing windows

Four RAC Exams

RAC US

RAC EU

RAC CAN

RAC Global

Regulatory functions throughout product lifecycle; covers all regulated health products Regulatory knowledge, critical thinking and analysis

FDA regulations and knowledge of other agencies involved in health products in US

European regulations and guidances from the European Commission, EMA, Competent Authorities

Health Canada regulations

International standards and guidelines (i.e., ICH, IMDRF, WHO and ISO)

Regulatory professionals submitting to, or involved with, regulatory authorities in the US

Regulatory professionals submitting to, or involved with, regulatory authorities in the EU

Regulatory professionals submitting to, or involved with, regulatory authorities in Canada

All regulatory professionals, especially those in Asia, Latin America and other locations not submitting to US, EU or Canada

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